[Federal Register: April 7, 2005 (Volume 70, Number 66)]
[Notices]               
[Page 17698-17699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap05-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0119]

 
Preparation for the International Conference on Harmonization 
Meetings in Brussels, Belgium; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of meeting.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
meeting to provide information and receive comments on the 
International Conference on Harmonization (ICH) in advance of its next 
next Steering Committee and Expert Working Group meetings in Brussels, 
Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is an 
Efficacy Brainstorming Session focusing on the review of the existing 
efficacy guidelines and their need for updating as well as potential 
new topics for consideration. To promote a fuller discussion of this 
topic the public meeting will be expanded to include public input on 
initiatives related to current ICH efficacy guidelines and consider 
needs for further information both within and between existing 
guidances. These initiatives include electronic source data, clinical 
development plan summaries, Health Level 7 structured product labeling, 
and other initiatives including information exchange standards (e.g., 
Electronic Common Technical Document (eCTD) and terminology standards).
    Date and Time: The meeting will be held on April 20, 2005, from 9 
a.m. to 5:30 p.m.
    Location: The meeting will be held at The DoubleTree Hotel and 
Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. A block 
of rooms for those wishing to attend the meeting have been set aside at 
the government rate. Please contact the hotel directly for your 
reservation: DoubleTree Hotel and Executive Meeting Center, 301-468-
1100, FAX: 301-468-0308.
    Contact Person: Sema Hashemi, Office of the Commissioner, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
FAX number), and written material and

[[Page 17699]]

requests to make oral presentations, to the contact person by April 14, 
2005.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.
    If you need special accommodations due to a disability, please 
contact Sema Hashemi at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint 
regulatory/industry project to improve, through harmonization, the 
efficiency of the process for developing and registering new medicinal 
products in Europe, Japan, and the United States without compromising 
the regulatory obligations of safety and effectiveness.
    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for medical product development among regulatory agencies. 
ICH was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. ICH is concerned with harmonization among the 
following three regions: The European Union, Japan, and the United 
States. The six ICH sponsors are the European Commission; the European 
Federation of Pharmaceutical Industries Associations; the Japanese 
Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical 
Manufacturers Association; the Centers for Drug Evaluation and Research 
and Biologics Evaluation and Research, FDA; and the Pharmaceutical 
Research and Manufacturers of America. The ICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
International Federation of Pharmaceutical Manufacturers Associations. 
The ICH Steering Committee includes representatives from each of the 
ICH sponsors and Health Canada, the European Free Trade Area and the 
World Health Organization. The ICH process has achieved significant 
harmonization of the technical requirements for the approval of 
pharmaceuticals for human use in the three ICH regions.
    The current ICH process and structure can be found at the following 
Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org. (FDA has verified the Web site address, 

but we are not responsible for subsequent changes to the Web site after 
this document publishes in the Federal Register.)
    Interested persons may present data, information, or views orally 
or in writing, on issues pending at the public meeting. Oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 2 p.m. Time allotted for oral presentations may be limited to 
10 minutes. Those desiring to make oral presentations should notify the 
contact person by April 14, 2005, and submit a brief statement of the 
general nature of the evidence or arguments they which to present, the 
names and addresses, phone number, FAX, and e-mail of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    The topics to be discussed are the topics for discussion at the 
forthcoming ICH Steering Committee Meeting and ICH Expert Working 
Groups. One of the topics for the upcoming ICH meeting is an Efficacy 
Brainstorming Session focusing on the review of the existing efficacy 
guidelines and their need for updating as well as potential new topics 
for consideration. The complete set of ICH Efficacy Guidelines may be 
found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org/ or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
 To promote a fuller discussion of this topic the public 
meeting will be expanded to include public input on initiatives related 
to current ICH efficacy guidelines and consider needs for further 
information both within and between existing guidances. These 
initiatives include electronic source data, clinical development plan 
summaries, Health Level 7 structured product labeling, and other 
initiatives including information exchange standards (e.g., eCTD and 
terminology standards).
    The agenda for the public meeting will be made available on April 
15, 2005, via the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/ICH_Spring2005.htm
.


    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7020 Filed 4-5-05; 11:53 am]

BILLING CODE 4160-01-S